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CABA-201

BIOLOGICAL5 trials

Sponsors

Cabaletta Bio

Conditions

Generalized Myasthenia Gravis (gMG)Interstitial Lung DiseasesLupus NephritisMultiple SclerosisMultiple Sclerosis (MS) - Relapsing-remittingMultiple Sclerosis (Relapsing Remitting)Multiple Sclerosis - Relapsing RemittingPemphigus Vulgaris

Phase 1

A Phase 1/2, Open-label, Safety and Dosing Study of Autologous CART Cells (Desmoglein 3 Chimeric Autoantibody Receptor T Cells [DSG3-CAART] or CD19-specific Chimeric Antigen Receptor T Cells [CABA-201]) in Subjects With Active, Pemphigus Vulgaris (RESET-PV)
RecruitingNCT04422912
Cabaletta BioPemphigus Vulgaris
Start: 2020-09-29End: 2029-01-01Target: 40Updated: 2026-05-29
RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus
RecruitingNCT06121297
Cabaletta BioLupus Nephritis, Systemic Lupus Erythematosus
Start: 2024-02-16End: 2029-12-01Target: 28Updated: 2026-08-26
RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis
RecruitingNCT06359041
Cabaletta BioGeneralized Myasthenia Gravis (gMG)
Start: 2024-12-17End: 2029-09-01Target: 24Updated: 2026-08-13
RESET-MS: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Multiple Sclerosis
WithdrawnNCT07006805
Cabaletta BioMultiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting, Multiple Sclerosis - Relapsing Remitting +4
Start: 2026-06-01End: 2029-10-01Updated: 2026-06-25

Phase 2

RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic Sclerosis
RecruitingNCT06328777
Cabaletta BioInterstitial Lung Diseases, Scleroderma, Systemic Sclerosis
Start: 2024-07-02End: 2029-07-01Target: 37Updated: 2026-08-17

Related Papers

Mechanistic basis of the acute safety profile of rese-cel, an autologous CD19-CAR T, in patients with autoimmune disease treated in four ongoing phase 1/2 clinical trials
Blood2025-11-03
RESET SLE: CLINICAL TRIAL EVALUATING CABA-201, A FULLY HUMAN, AUTOLOGOUS 4-1BB ANTI-CD19 CAR T CELL THERAPY IN NONRENAL SLE AND LUPUS NEPHRITIS
The Journal of Rheumatology2025-05-20